Urologists have long been aware of the inability of the current state of the art in medicine to surgically manage the failure of erection in men. Scardino first recognized the needs of these patients and realistically endeavored to reestablish a functionally erect penis by using a centrally placed acrylic rod beneath Buck's fascia on the dorsum of the penis. The result was a flaccid penis reenforced against buckling of the shaft, which provided for adequate vaginal penetration. Other pioneers, such as Goodwin and Scott, Lash, Zimmerman and Loeffler, and Pearman were among the early pioneers in the surgical rigid rod prosthesis. These early devices were not very satisfactory because they resulted in a semipermanent erection.
These centrally placed semirigid rod prostheses were soon replaced by paired semirigid rods implanted within the corpora cavernosa of the penis. Beheri, Small, Carrion and Gordon, and, more recently, Finney, have applied this surgical technique in an effort to provide a more nearly normal erectile state suitable for vaginal penetration and satisfactory intercourse. In this regard, these prosthetic devices have been satisfactory. They suffer, however, from a shortcoming common to all prior art in this area, i.e., they result in a semipermanent erection. Further, insertion of the rods is surgery, which has its own attendant risks. Finally, surgical implantation of these rods in the penis often removes the possibility of normal erection.
The hydraulically inflatable penile prosthesis, developed by Scott, Bradley and Timm, was first introduced in 1973 for surgical correction of organic impotence. This device comprises four parts: An inflate-deflate pump, a storage reservoir and paired inflatable cylinders composed of medical-grade silicone elastomer. This prior art requires major surgery for implantation of the removable cylinders and removes the possibility of normal erection. Unlike rods, these hydraulically inflatable prostheses can malfunction mechanically. Nonetheless, they were a great improvement over the use of paired semirigid rods. Unfortunately, the prior art techniques are medically hazardous.
Dr. William L. Furlow, in his article, "Inflatable Penile Prosthesis: Mayo Clinic Experience with 175 Patients", Urology, Volume XIII, Number 2, February, 1979, reported that, of 175 patients treated for impotence with an inflatable penile prosthesis, 37 had mechanical complications, such as buckling of the cylinder, rupture of the cylinder, loss of fluid, etc.; while 13 had pathological complications, such as infection or wound erosion. Kramer et al., in the article "Complications of Small-Carrion Penile Prosthesis", Urology, Volume XIII, Number 1, January, 1979, discusses the complications that occur from use of the Small-Carrion penile prosthesis, which is one of the most popular and widely used prosthesis known to the prior art. Seventy-six patients with impotence underwent insertion of the prosthesis. Twenty patients experienced postoperative complications. Seven of these twenty lost one or both parts of the prosthesis either by spontaneous extrusion or surgical removal. Two of the seven patients presented obstructive symptoms of the urinary tract and purulent urethral drainage. In both patients, the prosthesis eroded through the corpus cavernosum into the urethra and was spontaneously extruded. Among the problems noted as most frequent by Dr. Kramer included wound infection, erosion of the corpus cavernosum, migration of the prosthesis into the urethra, and problems with concealment.
All prior art known to the present inventor, therefore, requires relatively nontrivial surgery that can result in complications. The prostheses are either mechanically complicated and subject to failure or result in a permanent or semipermanent erection. In all cases, medical authorities agree that psychological trauma associated with use of the prosthesis is an important aspect of treatment of impotence. Finally, surgical procedures to correct impotence are not normally used on subjects who can have any regular erection, due to the fact that the surgical procedure generally prevents the possibility of a normal erection.